Effects of Imatinib Mesylate in Polycythemia Vera

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Niguarda Hospital
ClinicalTrials.gov Identifier:
NCT00430066
First received: January 31, 2007
Last updated: October 7, 2014
Last verified: October 2014
  Purpose

The purpose of this study is to determine the activity of Glivec 400 mg po daily, as single agent, in inducing a haematological response in Polycythemia Vera.

The patients will be asked to have additional bone marrow and blood samples collected: these samples will be used to evaluate how the disease is responding to the drug.


Condition Intervention Phase
Polycythemia Vera
Drug: Imatinib Mesylate
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Glivec (Imatinib Mesylate) in the Treatment of Polycythemia Vera

Resource links provided by NLM:


Further study details as provided by Niguarda Hospital:

Primary Outcome Measures:
  • Reduction of Haematocrit to less than 45%. [ Time Frame: 6-12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Response duration [ Time Frame: 6-12 months ] [ Designated as safety issue: No ]
  • Safety profile [ Time Frame: 6-12 months ] [ Designated as safety issue: Yes ]
  • Reduction in platelet count and spleen size [ Time Frame: 6-12 months ] [ Designated as safety issue: Yes ]
  • Reduction of incidence phlebotomies. [ Time Frame: 6-12 months ] [ Designated as safety issue: Yes ]
  • Symptoms improvement in patients. [ Time Frame: 6-12 months ] [ Designated as safety issue: Yes ]

Enrollment: 9
Study Start Date: February 2007
Study Completion Date: September 2012
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Imatinib Mesylate
400 mg/day by mouth for 6 months (+ 6 months in case of responsiveness)
Drug: Imatinib Mesylate
400 mg/die for 6 months

Detailed Description:

Hematocrit <45% in men or <42% in women at 1°evaluation within 6 months In case of complete or partial responsiveness, experimental treatment will be continued until 12 months In case of disease progression or treatment failure, experimental drug will be withdrawn and patient will be out of the study

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Polycythemia Vera requiring treatment with either phlebotomy or Hydroxyurea
  • Age >18 years
  • Signed written informed consent form

Exclusion Criteria:

  • Pregnancy or breast-feeding
  • Creatinine >3 max NV
  • Bilirubin >3 max NV
  • AST/ALT >3 max NV
  • Concomitant and severe psychiatric disorder
  • Concomitant neoplastic disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00430066

Sponsors and Collaborators
Niguarda Hospital
Investigators
Study Director: Enrica Morra, MD Divisione di Ematologia - Ospedale Niguarda Ca' Granda
  More Information

No publications provided

Responsible Party: Niguarda Hospital
ClinicalTrials.gov Identifier: NCT00430066     History of Changes
Other Study ID Numbers: CSTI571POLIVERA
Study First Received: January 31, 2007
Last Updated: October 7, 2014
Health Authority: Italy: Ministry of Health
United States: Food and Drug Administration

Additional relevant MeSH terms:
Polycythemia
Polycythemia Vera
Bone Marrow Diseases
Hematologic Diseases
Myeloproliferative Disorders
Imatinib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014